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enableCV ProPlege Peripheral Retrograde Cardioplegia Device
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- enableCV ProPlege Peripheral Retrograde Cardioplegia Device FDA UDI
- Generic Name
- Coronary sinus cannula FDA UDI
- Device Name
- ProPlege Peripheral Retrograde Cardioplegia Device FDA UDI
- Model / Reference
- PR9 FDA UDI
- Description
- ProPlege Peripheral Retrograde Cardioplegia Device FDA UDI
Identifiers
- Catalog Number
- PR9 FDA UDI
- Primary DI / UDI-DI
- 00840479400013 FDA UDI
- 510(k) Number
- K120780 FDA UDI
- FDA Product Code
- DWF FDA UDI
- GMDN Term
- Coronary sinus cannula FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4210 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Coronary sinus cannula
enableCV ProPlege Peripheral Retrograde Cardioplegia Device by enableCV, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coronary sinus cannula.
- Coronary artery cannula — LivaNova USA, Inc. · Class II
- DLP® — MEDTRONIC, INC. · Class II
- DLP® — MEDTRONIC, INC. · Class II
- PEAK MEDICAL — PEAK MEDICAL Distribution Inc · Class I
- DLP® — MEDTRONIC, INC. · Class II
- PEAK MEDICAL — PEAK MEDICAL Distribution Inc · Class I
- Coronary artery cannula — LivaNova USA, Inc. · Class II
- Edwards Lifesciences Retrograde Cardioplegia Catheter — Edwards Lifesciences LLC · Class II
Cleared under the same submission
K120780 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- enableCV, LLC
Sources (1)
- FDA UDI d36d868d-8fd7-4cad-895f-2d25f0fcda8a 38 fields · synced Jun 9, 2026